Notification Fee

According to the Ordinance (1993:876) on medical devices, the registration of a clinical investigation incurs a notification fee of SEK 20,000. The fee is invoiced by the MPA.

Requirements regarding reduction of fee for notification of a clinical investigation of a medical device

The Medical Products Agency may grant a reduction of fee if there are if there are exceptional reasons, i.e. following very special or extraordinary circumstances. If the applicant would like to apply for a reduction of charge, the grounds for why such reduction would be justified, should be clearly stated in the cover letter when submitting the clinical investigation notification. No advance notices regarding whether the charge may be reduced or not will be given by the Medical Product Agency, the notifications will be assessed on a case by case basis. The applicant should be aware that the assessment of the clinical investigation is initiated regardless of whether the reduction of fee is granted or not and presuppose that the entire fee should be paid when the notification has been submitted. This applies both for initial notifications and resubmissions.

A clinical investigation notification is not valid until a document with invoice details has been attached to the submission. A template document for providing invoice details can be found on  the "Notification and forms" page on the left. The assessment will not start until the application is valid. When a notification is deemed valid an invoice will be sent to the applicant. The invoice must be paid even if a fee reduction has been requested. If a reduction of fee should be granted, a repayment will be made.

 
 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information